Baricitinib Compared to Standard Therapy in Patients With COVID-19

Sponsor
Azienda Ospedaliero, Universitaria Pisana
Study ID
NCT04393051
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib Oral Tablet — DRUG
    Baricitinib will be administered by oral route at different dosages according to age and kidney function. The drug will be administered for 14 days, unless occurrence of discontinuation criteria.

Study Details

There is urgent need of an effective therapy for Covid-19. To date, the best treatment of SARS-CoV-2 infection is unknown. Baricitinib has been identified as potential treatment for 2019-nCoV acute respiratory disease, because of its immunomodulating and hypothesized antiviral activity. This is a multicenter randomized clinical trial that aims to evaluate the efficacy and safety of baricitinib in patients with SARS-CoV2 pneumonia. Patients will be randomized to receive or not baricitinib as adjunctive therapy. All patients will continue to receive the ongoing standard therapy: chloroquine/idrossichloroquine and low-molecular weight heparin (LMWH) eventually associated with ritonavir/lopinavir or darunavir/ritonavir will be allowed for all included patients. The primary endpoint measure is the efficacy of baricitinib in reducing the number of patients requiring invasive ventilation after 7 and 14 days of treatment. Secondary endpoints will be mortality rates and toxicity of baricitinib.

Key Dates

Start date
May 20, 2020
Status verified
May 2020
Primary completion
Jun 30, 2020
Completion
Jul 30, 2020

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BAR group
    Patients who will be assigned (after a computerized randomization) to the BAR group will. receive baricitinib as adjunctive therapy. Baricitinib will be administered at 4 mg daily via oral route for 14 days as add-on therapy or 2 mg daily via oral route (eGFR between 30 and 60 ml/min and for patients with age \>75 years old) for 14 days as add-on therapy
  • No Intervention: Control group
    Patients in the control group will continue to receive standard therapy.

Primary Outcome Measure

Need of invasive mechanical ventilation [ Time Frame: after 7 and 14 days of treatment ]

Central Contacts

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